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510(k) Data Aggregation
K Number
K120077Device Name
COMED K-SERIES MANUAL WHEELCHAIR
Manufacturer
Date Cleared
2012-05-14
(125 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
DANYANG COMED HEALTHCARE CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Its intended use is to provide mobility to persons restricted to a sitting position.
Device Description
The Comed K-Series Manual Wheelchair is a user-propelled, manually operated folding wheelchair that is indicated for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 9 degrees. It consists of a mechanical steel frame and nylon upholstery. Designed to be lightweight and foldable, the model is approximately 18" wide, approximately 16" deep, has a weight capacity of 220lbs, and weighs approximately 42lbs.
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